A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)

Phase 2

Completed

• Conditions: Acute Ischemic Stroke

• Registration Number: NCT00044057
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The purpose of this study is to determine if YM872 in combination with t-PA can reduce disability and brain damage from stroke. YM872 or placebo will be given as a continuous intravenous (iv) infusion for 24 hours. It is important that the study medication, YM872 or placebo, is administered prior to the completion of the t-PA administration. The clinical effects of YM872 in addition to t-PA will be determined by assessing neurological function and disability scores at follow up visits through Day 90 of the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-12
• Study First Submitted: 2002-08-16
• Study First Submitted QC: 2002-08-19
• Study First Posted: 2002-08-20
• Study Completion: 2003-01
• Status Verified: 2006-03
• Last Update Submitted: 2006-03-31
• Last Update Posted: 2006-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with acute ischemic stroke who are treated with alteplase within 3 hours of stroke onset (Onset is defined as the time that which the patient was last seen in a normal state, or bedtime for unwitnessed strokes occurring during the night).
• Patients who are able to provide written informed consent or have consent provided by a legally authorized representative.
• Patients who are at least 18 years of age.
• Patients who have a National Institutes of Health Stroke Scale (NIHSS) score of at least 7 but not more than 23 and who are conscious.
• Other criteria as specified in the study protocol

Exclusion Criteria

• Patients who are not eligible to receive treatment with alteplase (t-PA) due to brain hemorrhage, risk for hemorrhage, or other criteria.
• Patients who have stroke of the brainstem or cerebellum.
• Patients who have renal (kidney) disease or insufficiency.
• Patients who have active epilepsy or convulsions during the current stroke episode.
• Patients who are IV drug users or are inebriated.
• Patients who have a history of drug-related anaphylaxis.
• Patients who have taken sedatives, anticonvulsants, or any medication with sedating effects in the 10 days prior study enrollment.
• Patients who have taken more than 1.3 g of aspirin per day in the 2 days prior to enrollment.
• Patients who have a known vitamin hypersensitivity.
• Other exclusion criteria as specified by the study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (117)

University of South Alabama Stroke Center; 🇺🇸 Mobile, Alabama, United States

Good Samaritan Hospital; 🇺🇸 San Jose, California, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

East Bay Region Associates in Neurology; 🇺🇸 Berkeley, California, United States

Providence St. Joseph's Medical Center; 🇺🇸 Burbank, California, United States

Mercy San Juan Hospital; 🇺🇸 Carmichael, California, United States

University of California Davis Medical Center; 🇺🇸 Davis, California, United States

Scripps Memorial Hospital; 🇺🇸 Encinitas, California, United States

Grossmont Hospital; 🇺🇸 La Mesa, California, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

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